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Completed

NCT Number: NCT00726726

Drug Interaction Study With a Potential Alzheimer's Disease Compound

The purpose of this study is to determine whether BMS-708163 will effect the pharmacokinetics of the commonly prescribed medicines midazolam, warfarin, caffeine,omeprazole and dextromethorphan

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Bristol-Myers Squibb Clinical Pharmacology Unit

Hamilton, New Jersey, 08690, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male subjects
  • 18-45 yrs old inclusive

Exclusion criteria

  • Women

Treatment and study plan

Interacting drugs - Cooperstown Cocktail (midazolam, warfarin, (+ vitamin K), caffeine, omeprazole and dextromethorphan)

Drug

Capsules + Tablets + Oral solution, Oral, Midazolam: 5 mg, Warfarin: 10 mg (vitamin K 10 mg), caffeine: 200 mg, omeprazole: 40 mg, dextromethorphan: 30 mg once daily, Day 1, 1 Day

BMS-708163

Drug

Capsules, Oral, 150 mg, once daily, days 6-15, 10 Days

BMS-708163 + Cooperstown Cocktail

Drug

Capsules + tablets + Oral solution, Oral, BMS-708163: 150 mg + Midazolam: 5 mg, Warfarin: 10 mg (vitamin K 10 mg), caffeine: 200 mg, omeprazole: 40 mg, dextromethorphan: 30 mg, BMS-708163, once daily, days 16-20 midazolam,warfarin, (+ vitamin K), caffeine, omeprazole and dextromethorphan once daily on Day 16, 5 Days

Primary outcomes

  1. Pharmacokinetic effects of BMS-708163 on interacting drugs (midazolam, warfarin, caffeine, omeprazole, and dextromethorphan)

    Time frame: throughout the study

Secondary outcomes

  1. Safety variables (adverse events, vital signs, safety labs)

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Effect of Concomitant Administration of BMS-708163 on the Pharmacokinetics of Midazolam, Warfarin, Caffeine, Omeprazole and Dextromethorphan in Healthy Male Subjects by Administration of a Modified Cooperstown Cocktail

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 1, 2008
Registry last updated
Nov 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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